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BrainsWay Ltd.
3/6/2024
Good morning, everyone. My name is Chris, and I'll be your conference operator today. At this time, I would like to welcome everyone to Brainsway's fourth quarter and full year 2023 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Thank you. Troy Williams, Investor Relations from LifeSci Investors. You may begin.
Welcome to BrainsWay's fourth quarter and full year 2023 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Adar Levy, and Chief Financial Officer, Ido Marone. The format for today's call will be a discussion of recent trends and business updates from Adar, followed by a detailed discussion of the financials. Then we will open up the call for your questions. Earlier today, BrainsWay released financial results for the three and 12 months, December 31st, 2023. A copy of the press release is available on the company's investor relations website. Before I turn the call over to Hadar, I would like to remind you that this conference call, including both management's prepared remarks and the questions and answers session, may contain projections or other forward-looking statements regarding, among other topics, Brainsway's anticipated future operating and financial performance, business plans and prospects, and expectations for its products and pipelines. which are all subject to risks and uncertainties, including shifting market conditions resulting from geopolitical, supply chain, and other factors, as well as the use of non-GAAP financial information. Additional information regarding these and other risks are available in the company's earnings release and in its other filings with the SEC, including the risk factor section contained in Brandsway's Form 20F. I would like to turn the call over to Hadar. Hadar?
Thank you, Troy. Welcome, everyone, and thank you for joining us today. I'm excited to discuss the strong momentum that currently exists throughout our entire business, as well as our positive outlook for 2024. As a reminder, we previously set a goal to grow the company's 2023 top line over 2022, while targeting breakeven operating income and positive adjusted EBITDA in the fourth quarter. I am thrilled to report that we significantly exceeded those expectations. Specifically, our revenues grew 17% in 2023 as compared to 2022. Most importantly, we generated positive quarterly net income in the fourth quarter. In Q4, we also recorded positive adjusted EBITDA and cash flow from operations for the second consecutive quarter. While we have not historically done so, based on our strong performance in 2023 and the expectation that this significant momentum will continue throughout 2024, we are providing specific top-line annual financial guidance. For full year 2024, we expect revenue in the range of $37 million to $40 million. This would represent growth of 16% to 26% over full year 2023 revenue. In addition, anticipate that our profitability momentum and positive cash generation will continue throughout the remainder of 2024. As you can tell from our most recent results and expectations for 2024, we are confident in the upward trajectory of our overall business, as well as the current market dynamics and the opportunities that lay ahead. I'd now like to take a few moments to articulate exactly why we're so excited and what we are doing to leverage the momentum that so clearly exists. We continue to optimize our existing commercial process, including enhancing our emphasize on larger institutional and enterprise customers that are playing an increasingly important role within the industry. We remain focused on adding our deep TMS technology into this expanding large mental health group or networks. As our results indicate, we continue to execute well on this strategy. Recent key agreement include increased collaboration with growing mental health treatment provider based in the Western region of the United States. After a series of successive order, BrainSway's most recent delivery brought this provider installed base to a total of seven deep TMS systems. Moreover, our international business continued to perform extremely well. To this end, we extended the availability of our deep TMS technology in South Korea, where the most recent delivery of system increased the install base in this important country to over 20 systems. In the fourth quarter, revenue increased 50% year-over-year, and we shipped a net total of 60 systems. Moreover, Demand for the OCD treatment indication continued to grow as we shipped 64 OCD coils as add-on elements to certain new and existing systems. Approximately 50% of our total install base now includes OCD treatment capability. We expect further bottom-line improvement in 2024. In addition, we continue to be supported by an extremely strong balance sheet. having ended 2023 with $46.3 million in cash with no debt. Importantly, the commercial trends in our business continue to appear favorable. From a reimbursement standpoint, there is a growing list of payers that have reduced the patient eligibility requirements for TMS treatment. Most recently, a major private insurer in Louisiana covering 1.9 million lives went from four failed medication trials In order to attain further growth, we continue to achieve significant progress in expanding the clinical and real-world evidence in support of deep TMS in multiple large disease areas. Most recently, we published two important papers highlighting deep TMS in future potential applications. The first, published in Human Neuroscience, included the results from multiple trials demonstrating deep TMS as a novel therapeutic approach for Parkinson's disease. The compelling data from these studies involving a total of 220 Parkinson's disease patients showed that deep TMS treatment led to significant improvement in motor symptoms as well as meaningful impact on non-motor aspects of daily living and mood symptoms. A second paper published in the Journal of Clinical Medicine highlighted deep TMS for the treatment of late-life depression and included the positive result of a post-marketing study of 247 older adults suffering from major depressive disorder. The result showed a 79.4% response rate and 60.3% remission rate for patients receiving at least 30 treatment sessions. While the current FDA labeling does not extend to these older patients and further analysis is needed, we are very excited about these results as they suggest that BrainSway Deep TMS can potentially treat depression in older adult patients. Moving on, we also recently initiated the clinical evaluation of BrainSway's exclusive palatant rotational field TMS. All Deep TMS360 in two new feasibility trials. DeepTMS360 employs a method of stimulation that enables activation of greater numbers of neurons in the brain that currently available forms of TMS. One study will test the safety and efficacy of this technology in the field of rehabilitation following stroke. The second study will evaluate DeepTMS360 in OCD utilizing an accelerated protocol. We believe that our rotational field technology holds significant potential to change the current TMS paradigm and look forward to generating clinical data from these important studies. In closing, we believe BrainSway is in the strongest position it has ever been in. We are coming off a very strong 2023 and are now focusing 2024 top-line growth of at least 16%. In addition, looking even further ahead, we remain focused on leading innovation within the TMS industry, increasing our confidence in Brain3's ability to continue capturing significant market share, both in the US and internationally. With that, I will now turn the call over to Ido for his review of our fourth quarter and full year 2023 financial results. Ido?
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